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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting patients at risk.

Background

High-cost cancer medications like Herceptin have become an increasingly tempting target for thieves and counterfeiters in recent years. While they lack the ready market that some drugs like Viagra have, their extraordinary cost means extraordinary paydays.

The counterfeit scare also prompted legislators to pass new legislation in 2013 known as the Drug Quality and Security Act (DQSA), which contained extensive provisions meant to ensure better tracking of pharmaceutical products and enhanced penalties for counterfeiters.

The US has not been alone among highly regulated countries in facing these counterfeit risks. In April 2012, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) also warned consumers that it had found counterfeit copies of Avastin in the supply chain.

A New Scare

But the EU's new counterfeit cancer drug scare differs from the US example in a notable way. While the counterfeit cancer drugs found in the US were manufactured abroad and sold through unlicensed Internet pharmacies, the drugs flagged this week by the European Medicines Agency (EMA) were originally on the market legally before being stolen.

EMA was scarce on the details in its 16 April 2014 announcement, but said the drugs had likely been stolen in Italy from sources such as hospitals before being "tampered with and re-introduced under false credentials into the supply chain in some countries."

Italian law enforcement officials are also looking into whether additional drugs may have been stolen, EMA said.

While no harm has yet come to consumers, EMA said it remained concerned none the less. The counterfeit drugs contain falsified batch numbers and expiry dates, and have been diluted with an unknown liquid, and perhaps in other ways as well. Luckily, only a "small number of vials" is thought to be affected at this time, regulators said.

French officials said in a separate statement that the counterfeits had been found in Germany, the UK and Finland, but not in France.

The episode represents perhaps the most serious breach of the pharmaceutical supply chain since the introduction of the EU's Falsified Medicines Directive in January 2013, which is meant to prevent the entry of counterfeit or falsified medicines into the EU's supply chain.